Processing bag for component separator system and method of removing separated components

ABSTRACT

A centrifugal processing bag, system and method for separating the components of a mixed material is presented. The processing bag includes a hub and a first port for receiving the mixed material, where the first port includes an outlet positioned within the processing bag at a perimeter of the bag. The processing bag also including a second port having a second port inlet spaced proximate the hub and away from a central axis of the hub. The second port directs a separated material collected from the second port inlet out of the processing bag.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/474,739, filed Jun. 26, 2006, which is a continuation of U.S. patentapplication Ser. No. 10/211,143, filed Aug. 2, 2002. The contents of theforegoing applications are hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates in general to a component separationssystem, and more particularly to a system for separating bloodcomponents from whole blood. The principles of the present invention maybe applied in a centrifuge processing system or other extracorporealblood processing systems.

2. The Prior Art

Flexible processing chambers (bags) for processing biological cells in afixed volume centrifuge, and methods for use of such processing bags,e.g., by centrifugation, are known. For example, PCT patent applicationPCT/US98/10406 describes a flexible cell processing chamber having arotating seal to keep the contents of the chamber sterile duringprocessing (see also U.S. Pat. No. 5,665,048. Flexible processingchambers advantageously are disposable and thus suitable for single-usesterile applications.

For certain applications, such as blood processing including bloodcomponent separation, enzymatic conversion of blood type, and pathogeninactivation of blood components, it is desirable to remove portions ofmaterial separated by process, both light material and/or heavymaterial. Simultaneous processing of multiple separated material fromthe processing bag reduces the time and expense required to perform suchapplications. Present flexible processing chambers do not provide theability to perform independent simultaneous processing of multiplesamples.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide animproved component separator system that enables one or more componentsof a mixed material to be easily and continually separated using acentrifuge.

In one aspect of the present invention, a centrifugal processing bag foruse with a component separator system for separating the components of amixed material includes a hub and a first port for receiving the mixedmaterial. The first port includes an outlet positioned within theprocessing bag at a perimeter of the bag. The processing bag alsoincluding a second port having a second port inlet spaced proximate thehub and away from a central axis of the hub. The second port directs aseparated material collected from the second port inlet out of theprocessing bag.

In another aspect of the present invention, a centrifugal processing bagfor use with a component separator system for separating the componentsof a mixed material is provided where the processing bag includes a hubhaving a first port for receiving the mixed material. The first portincludes an outlet positioned within the processing bag proximate to thehub. The processing bag also includes a second port having a second portinlet positioned at a perimeter of the processing bag, where the secondport directs a separated material collected from the second port inletout of the processing bag.

In yet another aspect of the present invention, a centrifugal processingbag for use with a component separator system includes a hub having afirst port for receiving the mixed material, where the first portincludes an outlet positioned within the processing bag intermediatebetween the hub and a perimeter of the processing bag. The processingbag also includes a second port having a second port inlet positioned ata perimeter of the processing bag and a third port having a third portinlet positioned proximate the hub and spaced away from a central axisof the hub. The second port directs a first separated material collectedfrom the second port inlet out of the processing bag and the third portdirects a second separated material collected from the third port inletout of the processing bag.

In yet another aspect of the present invention, a centrifugal processingbag for use with a component separator system includes a hub, a filterhaving an inlet portion and an outlet portion and a first port forreceiving the mixed material. The first port includes an inletpositioned adjacent the hub and an outlet positioned within theprocessing bag at a perimeter of the bag. A second port is also includedhaving a second port inlet positioned adjacent the inlet portion of thefilter and a third port having an inlet positioned adjacent the outletportion of the filter.

In yet another aspect of the present invention, a centrifugal processingbag for use with a component separator system includes a hub, a filterhaving an inlet portion and an outlet portion, a first port forreceiving the mixed material having an outlet positioned adjacent thehub, a second port having a second port inlet positioned adjacent theinlet portion of the filter and a third port having an inlet positionedadjacent the outlet portion of the filter.

In still yet another aspect of the present invention, a centrifugalprocessing bag for use with a component separator system includes a hub,a first filter having an inlet portion and an outlet portion, a secondfilter having an inlet portion and an outlet portion, a first port forreceiving the mixed material having an outlet positioned intermediatebetween a perimeter of the processing bag and the hub, a second porthaving a second port inlet positioned adjacent the inlet portion of thefirst filter, a third port having an inlet positioned adjacent theoutlet portion of the first filter and a fourth port having an inletpositioned adjacent the outlet portion of the second filter.

In another aspect of the present invention, a method of separatingcomponents of a mixed material in solution includes providing a flow ofa mixed material in solution to a centrifugal processing bag in acomponent separator system, where the processing bag includes a hub, afirst port for receiving the mixed material and having an outletpositioned within the processing bag, a second port having a second portinlet positioned within the processing bag at a position to collect aseparated material. The method also includes centrifuging the processingbag such that components of the mixed material are separated from oneanother, and establishing a second flow of separated material from thesecond port.

In yet another aspect of the present invention a method of separatingcomponents of a mixed material in solution includes providing a flow ofa mixed material in solution to a centrifugal processing bag in acomponent separator system, where the processing bag includes a hubhaving a first port for receiving the mixed material and having anoutlet positioned within the processing bag, a second port having asecond port inlet positioned within the processing bag and a third porthaving a third port inlet positioned within the processing bag. Themethod also includes centrifuging the processing bag such thatcomponents of the mixed material are separated from one another,establishing a second flow of first separated material from the secondport and establishing a third flow of second separated material from thethird port.

In yet another aspect of the present invention, a method of separatingcomponents of a mixed material in solution includes providing a flow ofa mixed material in solution to a centrifugal processing bag in acomponent separator system, where the processing bag includes a hub, afilter having an inlet portion and an outlet portion, a first port forreceiving the mixed material and having an outlet positioned within theprocessing bag, a second port having a second port inlet positionedwithin the processing bag, and a third port having a third port inletpositioned within the processing bag. The method further includescentrifuging the processing bag such that components of the mixedmaterial are separated from one another, establishing a second flow offirst separated material from the second port and establishing a thirdflow of second separated material from the third port.

BRIEF DESCRIPTIONS OF THE DRAWINGS

Numerous other objects, features and advantages of the invention shouldnow become apparent upon a reading of the following detailed descriptionwhen taken in conjunction with the accompanying drawings, in which:

FIG. 1 is a system block diagram illustrating a system in which theblood product transfer apparatus of the present invention may beemployed;

FIG. 2A is a cross-sectional view of a processing bag for a componentseparator system according to a first embodiment of the presentinvention.

FIG. 2B is a side, cross-sectional view of a processing bag for acomponent separator system according to a first embodiment of thepresent invention.

FIG. 3A is a cross-sectional view of a processing bag for a componentseparator system according to a second embodiment of the presentinvention.

FIG. 3B is a side, cross-sectional view of a processing bag for acomponent separator system according to a first embodiment of thepresent invention.

FIG. 4A is a cross-sectional view of a processing bag for a componentseparator system according to a third embodiment of the presentinvention.

FIG. 4B is a side, cross-sectional view of a processing bag for acomponent separator system according to a third embodiment of thepresent invention.

FIG. 5A is a cross-sectional view of a processing bag for a componentseparator system according to a fourth embodiment of the presentinvention.

FIG. 5B is a side, cross-sectional view of a processing bag for acomponent separator system according to a third embodiment of thepresent invention.

FIG. 6A is a cross-sectional view of a processing bag for a componentseparator system according to a fifth embodiment of the presentinvention.

FIG. 6B is a side, cross-sectional view of a processing bag for acomponent separator system according to a third embodiment of thepresent invention.

FIG. 7A is a cross-sectional view of a processing bag for a componentseparator system according to a sixth embodiment of the presentinvention.

FIG. 7B is a side, cross-sectional view of a processing bag for acomponent separator system according to a third embodiment of thepresent invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The drawings, that are to be discussed hereinafter, illustrate aprocessing chamber/bag for receiving a mixed material for separation. Inparticular, a preferred embodiment of this invention is directed toseparating blood components of whole blood and directing them out of theprocessing bag.

Reference is now made to FIG. 1 which is a system block diagram of acentrifugal, blood processing system embodying the device for enablingtransfer of blood product between at least one blood storage bag and acentrifuge processing bag. Many of the components illustrated in FIG. 1are not described in detail herein. However, reference is made to U.S.Pat. No. 6,175,420 to Barry et al., granted Jan. 16, 2001 for a morecomprehensive description of fluid management portions of the system.Reference may also be made to U.S. Pat. No. 5,665,048 to Jorgensen,granted Sep. 9, 1997 for further descriptions relating to the centrifugeitself. Both U.S. Pat. Nos. 5,665,048 and 6,175,420 are incorporatedherein by reference, in their entirety.

FIG. 1 illustrates the vacuum/pressure chamber 10 in accordance with thepresent invention and the associated pump 12 that couples to theairtight containment chamber 10 by way of the tubing 14. FIG. 1 alsoillustrates the air supply at 16. Schematically illustrated within thechamber 10 are a series of blood product storage bags 20. Each of thesebags is supported from a hanger 22 by means of a securing loop 24associated with each bag. Individual lines or tubing from each bagcouples through the wall of the chamber by way an airtight fixture 26.FIG. 1 illustrates this fixture at the bottom of the chamber 10.However, in embodiments to be described in further detail hereinafter,the fixture is usually provided on the door end and at about a mid-levelposition in the door.

In FIG. 1 there is also illustrated a centrifuge 30 that may haveassociated therewith centrifuge processing bags 32. Also illustrated isthe distribution section 40 comprising a plurality of fluid managementcassettes 42 and a peristaltic pump 44. Also coupling to the cassettes42 is a saline supply or bag 45 and reagent compartment 46. Alsoillustrated is a waste bag 48 relating to the fluid managementcassettes.

Not specifically illustrated in FIG. 1, but considered as part of thesystem, is a computer controller, such as a processor control 50 thatcontrols, inter alia, operation of the components of the system inaccordance with the present invention.

FIGS. 2A-7B illustrate blood processing bags according to the variousembodiments according to the present invention, each of which isdescribed below. For each embodiment, mixed material 2 is introducedinto the blood processing bag and is separated into various componentsincluding light material component(s) 4 and heavy material component(s)6. Accordingly, after a predetermined period of time passes afterinitiation of centrifugation, an interface 8 a between the mixedmaterial 2 and light separated material 4 and an interface 8 b betweenthe mixed material 2 and the heavy separated material 6 exist. Theinterfaces are specifically illustrated in FIG. 2, but FIGS. 3-7 alsoinclude such interfaces.

These interfaces may be used to control processing (via the controller50) and the flow of mixed material into the processing bag and separatedmaterial out, and are detected by an interface detection sensor 96 asshown in FIGS. 4 and 7, positioned external or internal to the bag.

Accordingly, FIGS. 2A and 2B illustrates a cross-sectional view of acentrifuge processing bag 60 according to a first embodiment of thepresent invention. In this embodiment, lighter material/fluid separatedfrom the mixed material, while heavier material is retained. Moreover,to dilute, wash and/or process the heavy fluid, a solution that islighter than the heavy material may be run through the heavy material.

The processing bag 60 includes a bag 62 manufactured of a plasticmaterial or the like, having a central hub 64. The central hub houses afirst port 66, which is connected to an inlet 68 positioned at aperimeter of the processing bag. The first port may receive the mixedmaterial (i.e., whole blood) in a continuous flow and directs thereceived material to the perimeter of the processing bag.

A second port 65 is also included on the hub, which is connected to oneor more inlets 67 positioned around a perimeter of the hub. Thus, as thecentrifuge spins, and the components of the blood begin to separate, alighter blood component accumulates near the inlets 67 to the secondports and a heavier blood component accumulates near the perimeter ofthe processing bag.

FIGS. 3A and 3B illustrates a second embodiment according to the presentinvention. In this embodiment, heavier material/fluid is removed fromthe mixed material in the processing bag while retaining lightmaterial/fluid.

As shown, a processing bag 70 includes a plastic bag 72 having a centralhub 74 including a first port 71 for receiving mixed material toseparate and a second port 75 for directing a separated material out ofthe processing bag.

In contrast to the first embodiment, the outlet 73 of the first port 71within the processing bag is positioned adjacent the hub and the secondport 75 is connected to an inlet(s) 77 positioned at the perimeter ofthe processing bag in the second embodiment, so as to direct a heavierseparated component away from the processing bag.

One of ordinary skill in the art will appreciate that a solution that isheavier than the light material separated from the mixed material mayberun through the light material to dilute, wash and/or process the lightmaterial.

A third embodiment of the present invention is illustrated in FIG. 4. Inthis embodiment, both light and heavy separated materials may be removedfrom the processing bag. In addition, as discussed with the previous twoembodiments, a lighter solution, that is lighter than heavy separatedmaterial, may be run through the heavy material and a solution that isheavier than the light material may be run through the light material todilute, wash, and/or process the respective fluid.

Accordingly, a processing bag 80 shown in FIGS. 4A and 4B includes a bag82, and a hub 84 which includes a plurality of ports. A first port 86 ofthe plurality of ports receives mixed material for separation in theprocessing bag and is connected to an outlet 87 which is positionedintermediate in the processing bag between the hub and perimeter. Asecond port 88 directs a lighter separated material from the processingbag and may include a plurality of inlets 90 positioned adjacent thehub. The processing bag also includes a third port 92 for directing aheavier separated material away from the perimeter of the processing bagvia an inlet 94.

Mixed material is introduced into the processing bag via the firstport/outlet, and then is centrifugally separated. The light separatedmaterial departs the processing bag via the second port and the heavyseparated material departs the processing bag via the third port.

The number of inlets to the second and third ports is also variable,where a single or multiple inlets may be used depending upon design.Thus, as shown, the second port is in communication with inlets 90, andthird port 92 is in communication with a single inlet 94 ports.

The interface detector 96 may be used to locate the interface betweenseparated and mixed materials, and is used to maintain (in conjunctionwith an expressor system) proper separation and operational parametersfor the component separator system.

FIGS. 5A and 5B illustrates a fourth embodiment according to the presentinvention. In this embodiment, the processing bag separates and filterslight material/fluid from mixed material. Accordingly, the processingbag 100 according to this embodiment includes a bag 102 having a hub104. The hub, as with the previous embodiments, includes one or moreports for directing material into and/or out of the processing bag. Afilter material 106 having an outlet portion 108 positioned adjacent thehub and an inlet portion 110 facing a remainder of the processing bag.

The hub also includes a first port 112 having an outlet 114 forintroducing a mixed material into the processing bag. The outlet of thefirst port in this embodiment is positioned at a point on the perimeterof the processing bag. A second port 116 includes a plurality of inlets118 positioned adjacent the outlet portion 108 of the filter material.Thus, lighter separated material may depart the processing bag via thesecond port 116 after being filtered through the filter material.

A third port 120 includes an inlet 122 positioned at the inlet portionof the filter material. Accordingly, unfiltered, separated lightmaterial may depart the processing bag via the third port.

A fifth embodiment 130 of the present invention is illustrated in FIGS.6A and 6B. This embodiment allows separated heavy material to befiltered (or unfiltered) and removed from the processing bag. As shown,a filter material 134 is positioned along a perimeter of the processingbag 132 and includes an inlet portion 134 a comprising the innerdiameter of the filter material and an outlet portion 134 b comprisingthe outer diameter of the filter material. A first port 136 receives themixed material for separation, which is introduced into the processingbag via the first port outlet 138 positioned proximate to a hub 140 atthe center of the processing bag. A second port 142 includes a pluralityof inlets 143 (although one inlet is sufficient) positioned adjacent theoutlet portion 134 b of the filter material 134. A third port 144includes an inlet 146 positioned adjacent the inlet portion 134 a of thefilter material 134.

Thus, the second port enables filtered heavy, separated material via thesecond port inlet to depart the processing bag, with the third portenabling unfiltered, separated material via the third port inlet todepart the processing bag.

FIGS. 7A and 7B illustrates yet a sixth embodiment according to thepresent invention in which both heavy and light separated material maybe removed from the processing bag. Thus, processing bag 150 includesthe bag 152 having central hub 154 which includes access ports forintroducing and removing materials from the processing bag. As with theprevious aspects, a first port 156 introduces mixed material into theprocessing bag via a first port outlet 158 positioned intermediate inthe processing bag between the perimeter of the bag and the hub. A firstfilter material 160, having an inlet portion 160 a and an outlet portion160 b is positioned immediately adjacent the hub.

The processing bag also includes a second filter material 162 positionedalong the perimeter of the processing bag, which includes an inletportion 162 a comprising an inner circumference of the filter materialfacing in a direction toward the hub of the processing bag and an outletportion 162 b, comprising an outer circumference of the filter materialfacing in a direction toward the perimeter of the processing bag.

A second port 164 includes one or more inlets 166, which are positionedadjacent the outlet portion 160 b of the first filter material, so thatfiltered, light material separated from the processing bag. A third port168 includes an inlet 170 positioned adjacent the outlet portion 162 b,to collect filtered, heavy separated material. Additionally, a fourthport 172, having an inlet 174 positioned adjacent the inlet portion 162a of the second filter material, allows unfiltered, separated, heavymaterial depart the processing bag.

A fifth port 165 includes inlet 167 which collects unfiltered lightmaterial separated during processing can be retrieved from the bag.

In each of the above embodiments mixed material, for example, wholeblood, is introduced into the processing bag, through the first port,centrifuged, and expressed out of the processing bags through variousports to obtain various separated materials, and through various methods(examples given below). In addition, a solution that is lighter than aheavier separated material may be introduced into the processing bag viathe first port and first port outlet, to dilute, wash and/or process theheavy material (when collecting, for example, light separated material).Likewise, a solution that is heavier than the light material through thelight material to dilute, wash, and/or process light, separated material(when collecting, for example, heavy, separated material). In systems inwhich both heavy and light separated material is processed and removedfrom the processing bag, both light and heavy solutions may be used todilute, wash and/or process the heavy and light separated material,respectively.

In order to remove separated material components from the processing bagaccording to the embodiments described above, a variety of methods maybe used. For example, separated material may be removed from theprocessing bag by using a processing bag of fixed volume, andcontrolling the volume of material introduced into the bag. In addition,the volume of the processing bag may be controlled, through variousmethods, to allow mixed material into the bag and separated material outof the bag. To assist in removing separated materials from theprocessing bag, the interface detection sensor, positioned eitherinternal or external to the processing bag may also be used so thatadequate control of the separated material may be had. The interfacedetection sensor, in combination with the controller according to thepresent invention, determines how much of separated material exists atone time in the processing bag.

Alternatively, expressor bags, as disclosed in co-pending U.S. patentapplication Ser. No. 09/970,547, filed Oct. 3, 2001 (the disclosure ofwhich is herein incorporated by reference). Accordingly, expressor bagspositioned adjacent the processing bag are inflated (via gas or liquid)to press against the processing bag and force out material storedtherein. Other processing methods familiar to those of skill in the artmay also be used.

The present invention has numerous applications in the biotechnology andmedical fields. In general, the present invention and componentseparator system design can be applied to any industry where separationis a requirement. Accordingly, examples of such applications include:

Biotechnology

-   -   Separation of components from bioreactors and bio-fermentation        processes;    -   separation and processing of materials in waste management; and    -   general extraction, purification and concentration of materials        for industry use.

Medical

-   -   Cell washing;    -   enzymatic conversion of red cell to ECO;    -   pathogen inactivation;    -   glycosylation;    -   lipid filtration;    -   leukocyte reduction;    -   inter-operative cell salvage;    -   cryo-preservation;    -   de-glycerolization;    -   blood component separation; and    -   apheresis (red cell, plasma, platelets).

The embodiments presented are for use both single unit (processing bagor system) and multiple simultaneous unit (processing bag) processingapparatuses when considered with the referenced patents and patentapplications. Moreover, a plurality of processing bags may be used asindependent, simultaneous processors that work in parallel or can besequenced such that processes that require more than one bag can be runserially in two or more adjacent or non-adjacent processing bags.

Having now described a few embodiments of the invention, it should beapparent to those skilled in the art that the foregoing is merelyillustrative and not limiting, having been presented by way of exampleonly. Numerous modifications and other embodiments are within the scopeof ordinary skill in the art and are contemplated as falling within thescope of the invention as defined by the appended claims and equivalentsthereto. The contents of all references, issued patents, and publishedpatent applications cited throughout this application are herebyincorporated by reference. The appropriate components, processes, andmethods of those patents, applications and other documents may beselected for the present invention and embodiments thereof.

What is claimed is:
 1. A flexible centrifugal processing bag for usewith a component separator system for separating the components of amixed material, said flexible centrifugal processing bag having acontinuous interior processing volume and comprising: a. a hub having acentral axis; b. a first port for receiving said mixed material, whereinsaid first port includes an outlet positioned within the continuousinterior processing volume of said flexible centrifugal processing bagand spaced apart from the central axis a first distance; c. a secondport on the hub having two or more second port inlets positioned withinthe continuous interior processing volume of said flexible centrifugalprocessing bag and spaced apart from said central axis a seconddistance, wherein the second distance is different from the firstdistance, said second port for directing a separated material collectedfrom said two or more second port inlets out of said flexiblecentrifugal processing bag; and d. a flexible portion extending radiallyoutward in a direction transverse the central axis from the hub to anuninterrupted circular outer perimeter of said flexible centrifugalprocessing bag along which at least one component of said mixed materialis separated.
 2. The processing bag according to claim 1, furthercomprising an interface location detector for detecting a separatedmaterial.
 3. The processing bag according to claim 1, further comprisinga filter having an outlet portion positioned adjacent the hub and aninlet portion facing a remainder of the processing bag.
 4. Theprocessing bag according to claim 3, further comprising a third porthaving an inlet positioned adjacent the outlet portion of the filter. 5.The processing bag according to claim 4, wherein said third portincludes a plurality of third port inlets.